Who is an IRB and when should the clinical site and sponsor contact the IRB?

Base on ICH-GCP guidelines Institutional Review Boards (IRBs) are responsible for conducting ethical review of the study protocol. In clinical trials, patient safety is the first priority and therefore IRB responsibility is to make sure that the study protocol is ethical and the study staff/PIs are well trained and qualified to conduct a study. But how does the IRB oversee the clinical trial and when should the sponsor or the clinical site contact the IRB? Depending on the study and protocol it might be different. The following cases are the most common interaction between the sponsor/clinical site and the IRB:

Protocol and informed consent approval

When a clinical site is selected for a study, the IRB should approve the site and the protocol prior to patient enrollment. It’s not possible for the clinical site to start the trial without IRB approval. Also, any change in the protocol which is called ‘protocol amendment’ should be approved by the IRB.

Protocol deviation/violation

Protocol deviation includes any non-compliance with the research protocol that does not have a direct and significant effect on patient’s safety, rights and welfare. Examples of protocol deviation are enrolling a patient who is not eligible for the study and missed visits due to the patients’s schedule/traveling. A protocol violation is a deviation that puts patient on risk and can affect the integrity of data.

Any protocol deviation/violation should be reported to the IRB and the clinical site and PI are responsible for maintaining records in relation to deviations.

Continuing review of an approved and ongoing study

Most of the IRBs approve a protocol for a certain time (e.g. 12-month period); this means the study/protocol approval has an expiration date. Prior to the expiration date a renewal notice is send to the clinical site and sponsor. The clinical site must submit a continuing review form to the IRB in order to keep enrolling the patients and continuing the study. The IRB will review and determine if the continuation of the study is appropriate.

Study closure

Study closure may have different reasons, for example a sponsor can close a site if the clinical site was not able to enroll patients in the study in a specific time frame. Other reason for study closure can be due to the completion of the study. Regardless of the reason for the study closure, a Study Closeout Report must be sent to the IRB.

For all of the above events, the IRB has its own forms. Usually, the clinical site is responsible for completing and submitting the forms. However, sometimes the sponsor can submit the forms on behalf of the clinical site. For example, if there is any amendment or change in the ICF, the sponsor can send that to the IRB on behalf of the sites.